Bladder (Urothelial, Transitional Cell) CancerNCT06607250
Bp-MRI Based Multi-planar VI-RADS
An observational study of Bladder (Urothelial, Transitional Cell) Cancer and MRI, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, MRI
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 1 Feb 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected bladder tumors due to symptoms such as hematuria.
Who may be able to join
- Patients with indications of bladder cancer from preoperative assessments;
- Unrestricted by gender;
- Age of 18 years or older;
- Absence of contraindications for Magnetic Resonance Imaging (MRI);
- Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes.
Who cannot join
- Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;
- Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;
- Postoperative histopathology confirming non-urothelial bladder cancer;
- Inability to undergo surgery due to severe medical conditions, including heart failure, acute myocardial infarction, and severe cardiac or pulmonary diseases, rendering the patient unable to withstand routine surgical procedures;
- Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;
- Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements;
- Inability to provide written informed consent for participation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210009
About this study
Official title: Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.
All enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.
This study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer.
- Being tested
- MRI
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
All enrolled patients underwent multiparametric magnetic resonance imaging, encompassing T2-weighted imaging (T2WI) and magnetic resonance diffusion-weighted imaging (DWI), in the coronal, sagittal, and axial planes.
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer patients | Not described Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
VI-RADS score
All enrolled patients underwent multiparametric MRI, which included T2WI (coronal, sagittal, axial planes) and diffusion-weighted imaging (DWI) in the coronal, sagittal, and axial planes to evaluate the VI-RADS score. A VI-RADS score of ≥3 and ≥4 were used as cutoff values for the diagnosis of MIBC.
Measured: Immediately after enrollment
Secondary outcomes (4)
statistical analysis
Sensitivity, specificity in predicting muscle invasive bladder cancer.
Measured: 1 day
positive predictive value (PPV), negative predictive value (NPV)
statistical analysis
Measured: 1 day
the Receiver Operating Characteristic (ROC) curve
statistical analysis
Measured: 1 day
statistical analysis
the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Feb 2023
- Primary completion30 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607250
- Sponsor's protocol ID
- 2024-SR-353
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Biparametric MRI-based Multi-planar VI-RADS for Assessing Muscle Invasion in Bladder Cancer
- ClinicalTrials.gov ID
- NCT06607250
- Acronym / sponsor ID
- 2024-SR-353
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.
All enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.
This study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer patients | – | Radiation: MRI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected bladder tumors due to symptoms such as hematuria.
Key inclusion criteria (5 listed)
- Patients with indications of bladder cancer from preoperative assessments;
- Unrestricted by gender;
- Age of 18 years or older;
- Absence of contraindications for Magnetic Resonance Imaging (MRI);
- Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes.
Key exclusion criteria (7 listed)
- Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;
- Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;
- Postoperative histopathology confirming non-urothelial bladder cancer;
- Inability to undergo surgery due to severe medical conditions, including heart failure, acute myocardial infarction, and severe cardiac or pulmonary diseases, rendering the patient unable to withstand routine surgical procedures;
- Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAll enrolled patients underwent multiparametric magnetic resonance imaging, encompassing T2-weighted imaging (T2WI) and magnetic resonance diffusion-weighted imaging (DWI), in the coronal, sagittal, and axial planes. | Radiation | Bladder cancer patients |
Primary outcome
VI-RADS score
Time frame: Immediately after enrollment
All enrolled patients underwent multiparametric MRI, which included T2WI (coronal, sagittal, axial planes) and diffusion-weighted imaging (DWI) in the coronal, sagittal, and axial planes to evaluate the VI-RADS score. A VI-RADS score of ≥3 and ≥4 were used as cutoff values for the diagnosis of MIBC.
4 secondary outcomes
statistical analysis
Time frame: 1 day
positive predictive value (PPV), negative predictive value (NPV)
Time frame: 1 day
the Receiver Operating Characteristic (ROC) curve
Time frame: 1 day
statistical analysis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder (Urothelial, Transitional Cell) Cancer and MRI, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VI-RADS score (time frame: Immediately after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.